Filter Integrity Test System
Application
(1) Hydrophobic filter integrity testing (water intrusion test).
(2) Hydrophilic liquid filter integrity testing (forward flow and bubble point tests).
(3) Pre-use validation for single-use systems and small-scale process equipment.
(4) Liquid sterilizing filtration systems in pharmaceutical, biotechnology, and life sciences industries.
(5) Gas sterilizing filter integrity verification in the pharmaceutical industry.
(6) Laboratory environments under GMP and 21 CFR Part 11 control.
(7) Verification of various process liquid or gas filters, including laboratory and industrial production processes.
(8) Supports multiple membrane types, including hydrophobic, hydrophilic, and composite membranes.
Testing Standards
ASTM F838 – Membrane bubble point method
ASTM D5199 – Gas and liquid filtration membrane performance testing
ISO 2548 series – Pressure decay and diffusive flow methods
GMP/GDP Filter Validation Guidelines
FDA 21 CFR Part 11 – Data integrity compliance
Product Specifications
| Parameter | Technical Specifications |
|---|---|
| System Size | 1189 × 575 × 856 mm |
| System Weight | Approx. 120 kg (empty water tank) |
| Water Tank Capacity | 18 L (removable, manual/automatic filling) |
| Forward Flow Test Accuracy | ±3% or ±0.05 mL/min (whichever is larger) |
| Water Intrusion Test Accuracy | ±3% or ±0.02 mL/min (whichever is larger) |
| Bubble Point Test Accuracy | ±3% |
| Power Supply | 100–240 VAC, 50/60 Hz, typical power 150 W |
| Compressed Air Pressure | 4500–8000 mbar (58–116 psi) |
| Test Flow Range | FF: 0.1–1000 mL/min; WIT: 0.02–50 mL/min; BP: 400–6500 mbar |
| Test Resolution | FF: 0.1 mL/min (<10 mL/min: 0.01 mL/min); WIT: 0.01 mL/min; BP: 50 mbar |
| Touch Screen | 26.4 cm diagonal, 1024 × 768 pixels, backlit, adjustable contrast |
| Protection Level | IP54 (splash-proof) |
| Environmental Conditions | Operating temperature: 5–50℃; Storage temperature: -20–70℃; Relative humidity: 95% RH (non-condensing) |
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